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Objectives: Estimate HTLV-1/2 (human T-cell lymphotropic viruses) prevalence in Canadian blood donors and the association of demographic variables with infection and their corresponding risk factors., Methods: First-time blood donors in all Canadian provinces (except Quebec) from 1990 to 2022 were included. Blood samples were tested for HTLV-1/2 by enzyme-linked immunoassay, confirmed by Western blot. Multivariable logistic regression with year, age group, sex, region, neighbourhood material deprivation, and ethnocultural composition indices predicted HTLV-1/2. Since 2005, all HTLV-1/2-positive donors (cases) were invited to participate in a risk factor interview, and 4 non-positive donors (controls per case) were matched for age, sex, and region. Case-control predictors of HTLV-1/2 were analyzed using logistic regression., Results: There were 3,085,554 first-time donors from 1990 to 2022. HTLV-1/2 prevalence remained low (12 per 100,000 in 2022, 95% CI 6.4-23.5). The odds ratios predicting HTLV-1/2 were higher in females (2.0, 95% CI 1.5-2.6), older age groups (50 + ; 6.3, 95% CI 4.3-9.2), British Columbia and Ontario, those materially deprived (1.9, 95% CI 1.2-2.9), and those in ethnocultural neighbourhoods (7.5, 95% CI 3.2-17.3). Most HTLV-1/2 in Ontario was HTLV-1, whereas in British Columbia half were HTLV-2. Forty-three of 149 (28.8%) cases and 172 of 413 (41.6%) controls completed an interview. The strongest predictor of HTLV-1/2 in case-control analysis was birth in a high-prevalence country (OR 39.8, 95% CI 7.8-204.3) but about 50% of HTLV-1 and 90% of HTLV-2 were Canadian-born., Conclusion: HTLV-1/2 prevalence is low in blood donors. High-prevalence country of birth accounts for about half of HTLV-1; HTLV-2 positives are usually Canadian-born. HTLV-1/2 transmission likely occurs overseas and within Canada., (© 2024. The Author(s) under exclusive license to The Canadian Public Health Association.)

Background: The two Canadian blood suppliers, Canadian Blood Services and Héma-Québec, removed the time-based deferral for men who have sex with men and adopted criteria assessing sexual risk behaviors. We report the impact of these changes on the safety and adequacy of the Canadian blood supply., Study Design and Methods: Since 2022, all donors are asked if (1) they have had a new partner and (2) more than one sexual partner in the last 3 months. Donors answering yes to either question are asked if they had anal sex in the last 3 months; if yes, they are deferred for 3 months. We followed HIV rates for the 18 months before and 14 (Héma-Québec) or 18 months (Canadian Blood Services) post-implementation and interviewed HIV-positive whole blood donors. We assessed the number and characteristics of whole blood donors answering yes to the two first questions with or without deferral., Results: There were four HIV-positive donations out of 1,492,355 donations pre-implementation and four out of 1,447,772 post-implementation (0.27/100,000 vs. 0.28/100,000, p = 1.00). Post-implementation, one HIV-positive donor was non-compliant with multiple criteria, no risk factors were identified in the others. 3.2% of donors answered yes to questions (1) and/or (2); 0.17% were deferred for a new partner and/or more than one partner and anal sex. Deferral rates were highest in first time, younger donors, and similar in males and females., Conclusion: Implementation of sexual risk behavior donor screening resulted in unchanged HIV rates to date and a manageable deferral rate., (© 2024 AABB.)

Medication use is extremely common in blood donors. Blood centers use various methods to obtain a history of medication use, all of which have strengths and weaknesses. Some data are available to develop policies for medications that impact product quality, transmissible disease testing, and infectious risks. Many blood centers defer donors for use of a small number of highly teratogenic medications, as a precautionary measure. Others also defer for possible harms related to the pharmacologic effects of medications. However, a single exposure to a blood component containing medication, with immediate dilution in the recipient's blood stream, is a very different situation from ongoing use of medication in a patient, with steady state concentrations achieved over time. It is therefore highly unlikely that these effects are relevant for recipient safety., Competing Interests: Declaration of Competing Interest All authors declare no conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background and Objectives: The distribution of rare and specific red cell phenotypes varies between races and ethnicities. Therefore, the most compatible red cell units for patients with haemoglobinopathies and other rare blood requirements are most likely to be found in donors from similar genetic backgrounds. Our blood service introduced a voluntary question asking donors to provide their racial background/ethnicity. Results triggered additional phenotyping and/or genotyping., Materials and Methods: We analysed the results of additional testing performed between January 2021 and June 2022, and rare donors were added to the Rare Blood Donor database. We determined the incidence of various rare phenotypes and blood group alleles based on donor race/ethnicity., Results: Over 95% of donors answered the voluntary question; 715 samples were tested, and 25 donors were added to the Rare Blood Donor database, including five k-, four U-, two Jk(a-b-) and two D- - phenotypes., Conclusion: Asking donors about their race/ethnicity was well received by donors, and the resulting selective testing enabled us to identify individuals with a higher likelihood of being rare blood donors, support patients with rare blood requirements and better understand the incidence of common and rare alleles and red blood cell phenotypes in the Canadian donor population., (© 2023 International Society of Blood Transfusion.)

Background and Objectives: Policies regarding medication use vary between blood centres. We evaluated medication use in eligible Canadian Blood Services whole blood donors to inform possible process improvements and allow comparisons between donors and the general population., Materials and Methods: All donors are asked about medication use in the last 3 days, and medications and their reason for use are documented in our donor computer system. Donor computer records were reviewed from January 1, 2020, to March 31, 2022 to extract information on medications by donor age and sex; medications were grouped into therapeutic classes. Stability of medication use over time was determined in a random sample of 100 donors who made at least two donations in the study period., Results: One-third of successful (eligible) donors were taking medications; of these, 80% were on one or two medications. Five classes of medication accounted for 72% of medication use, and 13 classes account for 93% of use. Use remains relatively stable over time., Conclusion: Medication use is common, with a few classes accounting for most use. Drop-down lists and storage of information from one donation to the next may enhance efficiency., (© 2022 International Society of Blood Transfusion.)

Background and Objectives: Donor criteria for diabetes vary significantly. We describe our evolving policies for donors with diabetes, their contribution to the Canadian blood supply and their rate of syncopal reactions compared to other donors., Materials and Methods: All donors are asked if they have diabetes and have taken medications in the last 3 days. We assessed donors with diabetes on various medications, the number deferred over time, and syncopal reactions in donors with diabetes and other donors in our donor reaction database., Results: Policy changes allowing type 2 diabetic donors on oral hypoglycaemics alone, type 2 diabetic donors on oral medications and insulin and type 1 diabetic donors (all on insulin) to donate resulted in a decrease in deferrals from 450 to 22 donors annually. Of donors being treated with medication for diabetes, 11% are receiving insulin as part of their treatment. Syncopal reaction rates were low and not statistically different between diabetic and non-diabetic donors, although confidence intervals (CIs) are large., Conclusion: Policies decreased deferrals while maintaining safety. A longer observation period would strengthen these observations., (© 2022 International Society of Blood Transfusion.)

Background and Objectives: Donor eligibility questions and criteria for medical conditions vary between blood centres, suggesting that they are based more on local regulations or experience, rather than on published data, which are limited. As the donor population ages, medical conditions become more common. We assessed donor health assessment criteria at blood centre members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. Our aim was to compare eligibility criteria and determine their underlying basis., Materials and Methods: A REDCap survey was sent to blood centre participants, based on medical conditions of greatest interest suggested by the Donor Studies Team of the BEST Collaborative. Participants were asked about current donor health assessment questions, deferral criteria and the basis for their deferral policy (donor risk, recipient risk or both) for 20 medical conditions., Results: Complete responses were received from 26 blood donor centres (24 separate responses) representing a combination of hospital-based centres, large regional centres and community/national blood centres in 14 different countries. Most centres specifically ask about heart and lung conditions, whereas fewer than half inquire about kidney, gastrointestinal or neurological conditions. North American blood centres tended to be less restrictive, while regulatory restrictions are more prevalent in Europe. Most participants felt that the criteria were based on regulatory requirements or experience, rather than on published data., Conclusion: There is considerable variability in criteria by region. Ideally, criteria would be more evidence-based rather than based on regulatory requirements or experience. Deferral criteria must balance donor and recipient safety and maintain an adequate blood supply., (© 2022 International Society of Blood Transfusion.)

Background and Objectives: Efficiency in mitigating HIV transmission risk by transfusion may vary internationally. We compared HIV prevalence and incidence in blood donors across different jurisdictions in relation to those rates in the general population and differences in deferral practices., Materials and Methods: Data from 2007 to 2016 were collected in Australia, Brazil (São Paulo), Canada, England, France, Italy, Ireland, Japan, the Netherlands, New Zealand, Norway, Spain (Basque Country), USA (Vitalant) and Wales. For each country/region, the number of HIV antibody-positive donations and nucleic acid testing (NAT)-only-positive donations was broken down according to first-time or repeat donor status, along with the relevant denominators., Results: There is a modest correlation between HIV prevalence among first-time donors and HIV prevalence in the general population. However, rates of HIV-positive donations in repeat donors, a proxy for incidence, do not correlate with incidence rates in the general population. Rates in donors from Italy and Basque Country, where deferral criteria for men having sex with men are less stringent, are higher compared with most other jurisdictions. Rates of NAT-only-positive donations are extremely low and do not differ significantly after adjustment for multiple comparisons., Conclusion: Donor HIV rates are only weakly associated with those observed in the general population. Countries with less stringent deferral criteria have higher HIV rates in their donor population, but the rates remain very low., (© 2021 International Society of Blood Transfusion.)

Every blood center must determine blood donor eligibility criteria for donors with medical conditions, often based on very limited published data and variable practice. This manuscript briefly outlines possible impacts of donor medical conditions on donor and recipient safety and product quality, and describes the multidisciplinary approach used in Canada to think about donor criteria issues. Many years of experience are distilled into practical considerations in determining criteria, possible sources of information, and factors for successful change implementation, to hopefully assist medical and technical staff engaged in decision-making around donor eligibility., (© 2021 AABB.)

Background: The use of pre-/post-exposure prophylaxis (PrEP/PEP) may interfere with routine HIV screening. As a result, blood services worldwide have adopted a variety of deferral policies to mitigate increased residual risk. In this study, we evaluated the operational impact of modifying the donor health questionnaire (DHQ) to include explicit questions to assess PrEP/PEP exposure., Study Design and Methods: We conducted a retrospective study between June 2019 and October 2020 of all blood donors attempting to donate at Canadian Blood Services. Sixteen-months post-implementation, we summarized self-reported PrEP/PEP rates and their indications for use. We also assessed deferral rates and the sensitivity of using existing risk questions to defer people exposed to PrEP/PEP., Results: Of 1,122,075 donations, 89 people (eight per 100,000 donations) reported PrEP (64%)/PEP (34%) use in the last 4 months. People exposed to PrEP were more likely to be men (94%) and taking PrEP for lifestyle reasons (87%). In contrast, indications for PEP use included occupational exposure (50%) and sexual assault (27%). Most donors who answered affirmatively to PrEP/PEP exposure were deferred (96%). If potential donors were not directly asked about their PrEP/PEP use, the majority would not have been deferred for any other reasons (PrEP 32/57 (56%) and PEP 15/30 (50%))., Conclusion: Not all blood services have adopted direct questions to identify PrEP/PEP exposure; some rely on existing DHQ questions. In Canada, despite DHQ questions such as medication use in the last 3-days, more than half of people exposed to PrEP/PEP would not have been identified and deferred., (© 2021 AABB.)

Background: There are several strategies to reduce donor reactions. We report donor participation and reaction rates before and after implementing multiple measures at Canadian Blood Services., Study Design and Methods: We introduced a structured program of 500 mL of water and a salty snack pre-donation and applied muscle tension (AMT) during donation. Donors were not deferred for out of range blood pressure (BP); however, BP was measured in first time donors. Time on the donation chair post-donation was decreased from 5 to 2 min for repeat donors. We assessed participation rates using our quarterly survey of 10,000 recent donors. We extracted vasovagal reactions with loss of consciousness (LOC) from our operational database and compared pre-implementation (Oct 12,018-March 31,2019) and post-implementation (Oct 12,019-March 31,2020) periods., Results: Survey response rates varied from 11% to 16%. The percentage of donors who drank the water and ate the salty snack increased from 58% to 82% and 44% to 70% over 4 quarters; those performing AMT increased from 24% to 41%. Reactions decreased from 19.07 per 10,000 (744 reactions in 390,123 donations) to 14.04 per 10,000 (537 in 382,382 donations) (p < .0001). No first-time donors with high BP (n = 684) but 5 with low BP (n = 718) had reactions, CI were very large., Conclusions: Achieving optimal participation was challenging. After implementation of a donor wellness initiative based on best practice, rates of vasovagal reactions with LOC decreased by 25%. A larger dataset is necessary to assess the safety contribution of BP deferrals when other mitigation measures are in place., (© 2021 AABB.)

Background: Alternative screening questions could permit low-risk men who have sex with men (MSM) to donate blood without a time deferral. We performed a study to determine the proportion of current donors who may be deferred by various questions and their comfort with them., Study Design and Methods: Donors attending collection sites in Canada in January and February 2018 were offered one of two questionnaires but not both. Questionnaire 1 asked about risk behaviors; Questionnaire 2 rated comfort with the questions. Volunteers uncomfortable with questions participated in short qualitative telephone interviews to understand reasons. Quantitative data were analyzed using χ 2 statistics., Results: Of 36 241 donors attending, 31 904 (88%, Period 1) completed Questionnaire 1; of 34 947, a total of 30 278 (87%, Period 2) completed Questionnaire 2; 294 completed an interview. In the past 3 months 3.1% (95% confidence interval [CI], 3.1%-3.6%) had more than one partner; 6.0% (95% CI, 5.7%-6.2%) had a new partner; 6.7% (95% CI, 6.4%-6.9%) were in a nonexclusive relationship; 11.2% (95% CI, 10.9%-11.6%) had at least one of these; 3.7% (95% CI, 3.4%-3.9%) had anal sex; and 62.8% (95% CI, 62.2%-63.3%) had condomless sex. More than 6% were uncomfortable with each question, but more (17.2%; 95% CI, 16.8%-17.7%) were uncomfortable with anal sex. Key reasons for discomfort were questions being too personal and unclear safety benefit., Conclusion: Most donors are comfortable answering alternative questions (except very personal ones) but question the benefit. Implementing alternative questions would result in substantive deferrals. Other policies such as using an MSM capture question to ask additional questions only to MSM should be considered., (© 2020 AABB.)

The COVID-19 pandemic has major implications for blood transfusion. There are uncertain patterns of demand, and transfusion institutions need to plan for reductions in donations and loss of crucial staff because of sickness and public health restrictions. We systematically searched for relevant studies addressing the transfusion chain-from donor, through collection and processing, to patients-to provide a synthesis of the published literature and guidance during times of potential or actual shortage. A reduction in donor numbers has largely been matched by reductions in demand for transfusion. Contingency planning includes prioritisation policies for patients in the event of predicted shortage. A range of strategies maintain ongoing equitable access to blood for transfusion during the pandemic, in addition to providing new therapies such as convalescent plasma. Sharing experience and developing expert consensus on the basis of evolving publications will help transfusion services and hospitals in countries at different stages in the pandemic., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Iron deficiency is a global problem in women of child-bearing age and is associated with adverse maternal and newborn outcomes. Repeated blood donations deplete iron stores and decrease hemoglobin levels. However, the clinical impact of iatrogenic iron deficiency on mothers and neonates due to blood donation is uncertain. The objective of this study was to assess the association between repeated blood donations in female donors of child-bearing age and the associated risk of adverse maternal and neonatal outcomes. We undertook an observational cohort study of all women who delivered a live or stillborn infant in Ontario, Canada, between 1 January 2010 and 31 March 2012 using birth record data from the Better Outcomes Registry & Network, Canadian Blood Services, and the Institute of Clinical Evaluative Sciences. Only a woman's first pregnancy within the study time frame was included for analysis. We excluded women <18 years or >50 years of age at the time of delivery and multiple birth pregnancies. Data on all female donors who made whole blood donations between 1 January 2007 and 31 March 2012 were obtained from Canadian Blood Services. The primary newborn outcome was diagnosis of a small-for-gestational-age neonate (less than 10th centile). Secondary outcomes were preterm birth, stillbirth, APGAR <4 at 5 minutes, cord pH <7, neonatal death, maternal transfusion, infection, preeclampsia, gestational hypertension, gestational diabetes, placental abruption, and maternal death. Regression models evaluated the effect of repeated donation and the time interval between donations and conception on neonatal and maternal outcomes while adjusting for important clinical and demographic risk factors. A total of 260 037 women delivered live or stillborn singleton infants between 1 January 2010 and 31 March 2012. A total of 7919 (3.0%) women were blood donors, with a mean of 2.43 ± 2.10 lifetime donations. Mean maternal age at the time of delivery for nondonors and donors was 30.30 ± 5.38 and 29.74 ± 4.94 years, respectively. Small for gestational age occurred in 23 706 (9.4%) of neonates born to nondonors and 526 (6.6%) of neonates born to donors. There was a reduction in the risk of small for gestational age with increasing number of lifetime donations (adjusted odds ratio 0.89 [0.86-0.92] per additional donation). For the prespecified secondary outcomes, we observed a reduction in the risk of low birth weight (adjusted odds ratio 0.95 [0.91-0.98] per additional donation). There was no association with other secondary neonatal or maternal outcomes except for maternal hypertension. Proximity of donation to conception had no effect on risk of a small-for-gestational age neonate. Our data suggest that there is no increased risk of deleterious neonatal and maternal outcomes associated with repeated blood donations prior to pregnancy. Although possibly a result of a healthy donor effect, our findings are reassuring to female donors and their children as well as to clinicians and blood system stakeholders seeking to inform policy decisions., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Determination of blood donor hemoglobin (Hb) levels is a pre-requisite to ensure donor safety and blood product quality. We aimed to identify Hb measurement practices across blood donation services and to what extent differences associate with low-Hb deferral rates., Methods: An online survey was performed among Biomedical Excellence for Safer Transfusion (BEST) Collaborative members, extended with published data. Multivariable negative-binomial regression models were built to estimate adjusted associations of minimum donation intervals, Hb cut-offs (high, ≥13.5 g/dL in men or ≥ 12.5 g/dL in women, vs. lower values), iron monitoring (yes/no), providing or prescribing iron supplementation (yes/no), post-versus pre-donation Hb measurement and geographical location (Asian vs. rest), with low-Hb deferral rates., Results: Data were included from 38 blood services. Low-Hb deferral rates varied from 0.11% to 8.81% among men and 0.84% to 31.85% among women. Services with longer minimum donation intervals had significantly lower deferral rates among both women (rate ratio, RR 0.53, 95%CI 0.33-0.84) and men (RR 0.53, 95%CI 0.31-0.90). In women, iron supplementation was associated with lower Hb deferral rates (RR 0.47, 95%CI 0.23-0.94). Finally, being located in Asia was associated with higher low-Hb deferral rates; RR 9.10 (95%CI 3.89-21.27) for women and 6.76 (95%CI 2.45-18.68) for men., Conclusion: Differences in Hb measurement and eligibility criteria, particularly longer donation intervals and iron supplementation in women, are associated with variations in low-Hb deferral rates. These insights could help improve both blood donation service efficiency and donor care., (© 2020 AABB.)

Background: This study examined the impact of age and sex of first-time donors who had not experienced an adverse event or deferral on their likelihood of and time to return., Study Design and Methods: On behalf of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative, international blood collection agencies (BCAs) were invited to provide data on first-time whole blood donors in 2014, including initial presentation date, collection site type, age, sex, blood type, return to donate within 24 months (yes/no), and subsequent presentation date., Results: Eight BCAs contributed 706,789 records. The overall odds of returning to donate were slightly lower in female versus male donors, and the overall age trend was U-shaped with younger and older donors having higher odds for returning relative to middle-aged donors. However, variations by BCA were observed. Specifically, in three BCAs, women had higher odds of returning to donate than men. Further, while across seven BCAs the smallest cohort of older first-time donors returned at a higher rate and returned more quickly than middle-aged first-time donors, the behavior of younger donors varied substantially between BCAs., Conclusion: While older first-time donors are more likely to return and return more quickly than middle-aged donors they make up only a small proportion of first-time donors, whereas the larger group of younger donors exhibits less clear patterns of return compared to middle-aged donors. Further research is needed to determine whether targeting the recruitment of older donors or bolstering retention of middle-aged donors would be most effective in maintaining the blood supply., (© 2019 AABB.)

Background: To reduce donor iron deficiency in whole blood donors, we changed our hemoglobin (Hb) cutoff in males and interdonation interval in females., Study Design and Methods: A change in messaging to females in fall 2016 was followed by changing the interdonation interval from 56 to 84 days in the appointment booking system (December 2016) and actual donation criterion (March 2017). The minimum Hb for males increased from 125 g/L to 130 g/L (March 2017). We evaluated Hb levels and deferral rates, donor presentations with a Hb level below 120 g/L, donation frequency, and donor base size before and after these changes., Results: The Hb deferral rate decreased in females from 13.0% to 9.5%, increased in males from 1.2% to 2.1%, and decreased overall from 6.8% to 5.4% (all p < 0.001). Mean Hb increased from 135.0 g/L to 136.2 g/L in females and from 149.9 g/L to 150.6 g/L in males (both p < 0.0001). The percentage of presentations with Hb below 120 g/L decreased by 27% in males and females (p < 0.001). Annual donation frequency decreased by 12% in females and 4% in males; the donor base was expanded by 5.8%., Conclusions: Many positive impacts were seen for female donors, including a shift in the Hb distribution curve to the right, and a large reduction in Hb deferrals. For males, there was an increase in Hb deferrals and a small increase in mean Hb. Changes were related to both reduced donation frequency and a shift in composition of the donor base., (© 2019 AABB.)

Background: Some countries impose an upper age limit on whole blood and double RBC donation while others do not. We evaluated the safety of blood donation in older individuals (≥71 years), and their contribution to the blood supply of five countries., Study Design and Methods: Twelve blood center members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative from four countries with no upper age limit for whole blood and double RBC donation (Canada, New Zealand, England, and the United States) or an upper age limit of 80 (Australia) provided 2016 data on donors and donations, deferral rates, and vasovagal reactions by donor age and sex. Donors under age 24 were included in the number of total donors and donations, but not in deferral and reaction rate comparisons., Results: Older donors accounted for 1.0% (New Zealand) to 4.3% (United States) of donors, and 1.5% (New Zealand) to 5.6% (United States) of donations; most were between ages 71 and 76. The deferral rate was higher in older compared to 24- to 70-year-old males, but very similar between older and younger females. In contrast, vasovagal reaction rates were either lower (male donors) or similar (female donor for reactions with loss of consciousness) in older compared to 24- to 70-year-old donors., Conclusions: Exclusion solely based on older age appears to be unwarranted based on safety concerns such as donor reactions. Healthy older individuals can continue to safely donate and make a significant contribution to the blood supply past arbitrary age limits., (© 2019 AABB.)

Background: We assessed donor return rates, donation frequency, and factors related to the evolution of ferritin levels 2 years after entering donors into a large operational study of ferritin testing., Study Design and Methods: Ferritin testing was done on donors from representative clinics (n = 12,595). Low-ferritin donors (<25 μg/L) were informed and not called for 6 months to book a donation. Approximately 37% of donors had ferritin retested on a return donation. Return rate and donation frequency were monitored, and a logistic regression model was constructed., Results: The return rate was lower in low-ferritin donors (67% vs. 78%), particularly in women who were first-time donors (36% vs. 61%). Returning low-ferritin donors made fewer donations in the 2 years after notification compared to the 2 years prenotification (4.5 vs. 7.5 for men, 3.0 vs. 5.0 for women), while donation frequency was lower and increased slightly for normal-ferritin donors (4.7 vs. 4.4 for men, 3.6 vs. 3.1 for women). An increased number of donations, shorter interdonation intervals, female sex, and younger age are associated with low ferritin levels on initial and repeat testing. Some recovery of ferritin occurred, but most low-ferritin donors continued to have low or borderline levels on retesting., Conclusion: Informing donors of low ferritin results had a long-lasting impact on return rates and donation frequency, requiring recruitment efforts to maintain adequacy of supply. Increasing the interdonation interval leads to some improvement in ferritin levels; more sustained efforts to encourage donors to improve iron intake are needed to achieve long-term benefit., (© 2018 AABB.)

We review the history and evolution of blood donor criteria for men who have sex with men (MSM). Deferral policies in many jurisdictions, including Australia, New Zealand, Canada, the United States, Brazil and many western European countries are based on a period of abstinence from MSM, often of 12 months duration. Several countries (Italy, Spain and Portugal) defer donors based on sexual behaviours considered to be at high risk, regardless of whether the partner is same sex or opposite sex. Compliance is a key determinant in the efficacy of any deferral policy. We summarize research themes and strategies discussed at a January 2017 meeting held in Toronto, Canada, to provide an evidence basis for future policy changes., (© 2017 The Authors Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.)

Background: We compared donor and general population demographics over time to provide insight into current donation patterns and the future adequacy of the blood supply., Study Design and Methods: Seventeen blood center members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative from 12 countries provided the number of donors and people in the general population by demographic category for 2001 and 2011, changes in age criteria, and percentage of first-time donors. We calculated the median age of donors and the general population and determined the percentage of each group in age and sex cohorts., Results: Age criteria vary, with upper limits recently liberalized in several countries. In 2011, the percentage of first-time donors ranged from 10% to 41%. The median age of the donor and general population increased from 2001 to 2011 in most countries, as did the percentage of the general population over 60. The youngest donor cohort is overrepresented to a variable degree; this tendency increased over time. Although still underrepresented, older donors contributed more in 2011. A large middle-aged cohort is aging at a rate exceeding the progression of time, while 25- to 45-year-olds are relatively underrepresented., Conclusions: All participating countries are experiencing aging of their general population. Donor demographics differ substantially between countries; this can be only partly explained by population demographics and age criteria. Many countries have an aging middle-aged donor and population cohort and are increasingly relying on their youngest donors to contribute disproportionately to the blood supply., (© 2017 AABB.)

Background: We assessed risk groups for iron deficiency and the feasibility and efficacy of ferritin testing in a large blood center., Study Design and Methods: Donors were informed of possible testing in the predonation pamphlet. Plasma ferritin was measured on retention samples (n = 12,595) from representative clinics. Low-ferritin donors (<25 µg/L) were sent a letter and information sheet and not called for 6 months. Ferritin testing was repeated on 25% of donors; donor return rate and frequency were monitored., Results: Low-ferritin donors represented 2.9% of first-time and reactivated (no donation in past 12 months) male donors, 32.2% of first-time and reactivated female donors, 41.6% of repeat male donors, and 65.1% of repeat female donors. A mean of 11.7 months after index donation, the return rate was 76% for normal and 58% for low-ferritin donors; returning low-ferritin donors had made approximately one fewer donation. Ferritin increased by 16.3 and 12.1 µg/L in male and female low-ferritin donors and decreased by 17 µg/L in male and female normal-ferritin donors., Conclusion: The minimum hemoglobin level will be increased to 130 g/L for male donors and the minimum interdonation interval changed to 84 days (four donations yearly) for female donors based on iron deficiency risk groups. Large-scale ferritin testing was feasible. Donors informed of low-ferritin results had a lower return rate, donated less often, and had an increase in ferritin on return, approximately 1 year after initial testing, compared to donors with normal ferritin results., (© 2016 AABB.)

Purpose of Review: The review summarizes recent publications on the contentious issue of donor deferral criterion for men who have sex with men (MSM)., Recent Findings: Recent studies from the United States and China demonstrated that MSM is still a frequent risk factor for HIV-positive donors. Noncompliance is an important factor in the overall risk of HIV transmission but does not appear to be affected by the length of the deferral period. A major US study found a 2.6% noncompliance rate with the current indefinite deferral for MSM; similar or lower rates were found in other jurisdictions with shorter deferral periods. Several countries have had a defined deferral period of 1 year or 5 years in place long enough to determine that increases in HIV-positive cases predicted by modeling studies did not actually occur, suggesting that the assumptions made in these models are overly conservative., Summary: In summary, MSM eligibility policies are slowly changing around the world, with the US FDA now permitting a 1-year deferral. Transparency, involvement of stakeholders, and careful evaluation of risk and societal benefit should be part of future policy discussions on this issue.

Background: Informing donors of their ferritin status is one possible mitigating strategy to reduce iron deficiency in donors., Study Design and Methods: We evaluated the impact of informing donors of their ferritin status on their donation frequency, understanding of iron needs, and actions to improve iron intake 2 years after their inclusion in a prospective observational cohort study., Results: Informing donors of low ferritin results decreased return rate in first-time and repeat donors, and the median number of donations declined from three to two donations/year in returning donors with low ferritin on index donation compared to an increase from 1.5 to 2.5 donations/year in donors with normal ferritin. An electronic questionnaire demonstrated that approximately 60% of low ferritin donors saw their primary medical practitioner, and half of this group started iron. Qualitative interviews revealed suboptimal understanding of iron needs and poor compliance with iron supplementation., Conclusion: Providing donors with results of ferritin testing may reduce return rates and donation frequency in the 2 years after testing. Simply providing donors with ferritin results and an information sheet is often inadequate to improve donors' understanding of iron needs and may not lead to a substantive increase in iron intake over time., (© 2016 AABB.)

Background: The deferral for men who have sex with men (MSM) changed from a permanent deferral since 1977 to a 5-year deferral on July 22, 2013, in Canada. We assessed the impact on safety and adequacy of the blood supply at Canadian Blood Services., Study Design and Methods: Human immunodeficiency virus (HIV) rates were monitored from January 1, 2010, to July 21, 2015. Risk factors were assessed in notification interviews. Anonymous online surveys of male whole blood donors assessed compliance before and after implementation., Results: HIV rates were 0.2, 0.5, and 0.51 per 100,000 donations in 2010 to 2012; they were 0.54 and 0.22 in the first and second years after implementation (p = 0.8). Of four male HIV-positive donors after implementation, three denied risk factors and one knew he had HIV. Before implementation 9669 of 19,437 (49.7%) donors participated in the survey, and after implementation, 6881 of 18,934 (36.3%). Before implementation 0.67% of male donors were noncompliant, and after implementation, 0.44%. There was no difference before versus after implementation in male donors with MSM history in the past 5 years (0.37% vs. 0.43%, p = 0.54). After implementation, eligible MSM donors increased (0.42% vs. 0.66%, p = 0.04), with approximately 500 more donors in 2014., Conclusion: Implementation of a 5-year deferral for MSM had no impact on HIV rates in 2 years of postimplementation monitoring. Donor compliance improved after implementation due to MSM donors who were previously ineligible becoming eligible. There was no change in the percentage of male donors with recent male partners but there was a modest increase in eligible MSM in the donor pool., (© 2015 AABB.)

Standard definitions of donor reactions allow each blood establishment to monitor donor adverse events and compare with other organizations to develop best practices. The ISBT Haemovigilance Working Party leads a multi-organizational effort to update the 2008 ISBT standard for surveillance of complications related to blood donation. Revised definitions have been developed and endorsed by the ISBT, AABB, International Haemovigilance Network (IHN) and other international organizations., (© 2015 International Society of Blood Transfusion.)

Background: The introduction of molecular methods into routine blood typing is prompting the identification of new blood group alleles. Discrepancies between the results of genotyping and serology or chance events uncovered during genotyping prompted additional investigations, which revealed six new RHCE variant alleles., Study Design and Methods: Samples from eight blood donors, two patients (one prenatal), and a patient's relative, all of diverse racial origin, were analyzed by standard serology methods, targeted genotyping arrays, DNA sequencing, and allele-specific polymerase chain reaction., Results: Six new RHCE alleles were identified, namely, RHCE*cE84A, RHCE*ce202G, RHCE*ce307T, RHCE*Ce377G, RHCE*ce697G,712G,733G,744C, and RHCE*Ce733G., Conclusion: While implementation of new assays in commercial genotyping platforms to detect the polymorphisms reported here may not be justified given their apparent rarity, software interpretative algorithms may benefit from the identification of new alleles for a more accurate determination of genotypes and prediction of phenotypes., (© 2015 AABB.)

Background and Objectives: Mandatory predonation reading materials inform donors about risk factors for transmissible disease, possible complications of donation and changes to the donation process. We aimed to assess the attention to predonation reading materials and factors which may affect attention., Materials and Methods: A national survey in 2008 of 18,108 blood donors asked about self-assessed attention to reading the materials. In face-to-face interviews, 441 donors completed additional questions about reading the materials and a literacy test. Qualitative interviews of 27 donors assessed their approach to reading., Results: In the national survey, most of the first-time donors said they read all or most of the materials (90.9% first-time vs. 57.6% repeat donors, P < 0.001) and 66% vs. 23.1% reported reading them carefully (P < 0.001). In face-to-face interviews comparing those who read materials carefully, skimmed or did not read, most knew that donors are informed of positive transmissible disease test results (97.1%, 95.5, 98.0 P > 0.05), but fewer recalled seeing the definition of sex (77.2%, 56.9, 24.2 P < 0.001). Literacy was poor (30.5% frustration level, 60.3% instructional, 9.2% independent) but similar when those who read materials carefully, skimmed or did not read were compared (P > 0.05). Qualitative interviews showed that donors are reluctant to read any more than necessary and decide based on perceived importance or relevance., Conclusion: Attention to predonation reading materials tends to be better among first-time donors. The effectiveness is limited by low motivation to read, especially for repeat donors, as well as poor literacy., (© 2015 International Society of Blood Transfusion.)

A downward trend in preoperative autologous donation (PAD) continues in Europe and the Americas, with many jurisdictions only funding medically necessary collections at present. This is the result of decreasing real and perceived residual risks of allogeneic transfusion-transmitted disease and the declining need for transfusion due to patient blood management, which have also led to escalating logistical and cost constraints for PAD programs. We outline collection trends in North America, Europe, and Latin America and review the benefits, risks, effectiveness, and safety of PAD. Important elements of informed consent follow from these points. Evidence-based medical criteria for PAD and autologous transfusion are discussed as are methods to optimize autologous collection timing to regenerate donated red cells. Recommendations for identification of patients whose risk-to-benefit ratio suggests substantial benefit compared with other autologous blood salvage and anemia management alternatives conclude the review., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: To investigate the long-term consequences of repeated plasmapheresis on donor health, their donation histories and demographic data were reviewed to determine the frequency of development of monoclonal (Mc) gammopathies or other gamma globulin abnormalities (OGGAs)., Study Design and Methods: Samples from apheresis plasma donors collected at Canadian Blood Services were tested initially and every 4 months for total protein (TP) followed by serum protein electrophoresis (SPE). Out-of-range samples or those showing abnormal band patterns were forwarded to a hospital laboratory for additional investigation., Results: Of 52,972 donors who donated 471,446 apheresis plasmas over 9 years, 89,490 samples were sent for TP and SPE testing. Of 3005 samples forwarded for further investigation, abnormal immunofixation electrophoresis (IFE) results were found in 209 (0.4%) donors, 85 from first-time (FT) and 124 from repeat (RPT) plasma donors during participation in the program. There were 167 donors with Mc gammopathies (73 FT, 94 RPT) and 42 with OGGAs (12 FT, 30 RPT). FT or RPT donors with Mc gammopathies or OGGAs were significantly older than those with normal SPEs. RPT donors with Mc gammopathies or OGGAs also had a longer donation period than donors with normal SPEs., Conclusions: The incidence of Mc gammopathies (2.41 per 1000 donors) did not significantly increase from 2004 to 2012. Older donors had a higher incidence of Mc gammopathies and longer donation periods than their healthy counterparts. Overall, gammopathy rates were below those reported over the same age range in the general population., (© 2015 AABB.)

Correct donor D typing is critical to prevent recipient alloimmunization. No method can detect all variants, and the immunogenicity of many variants is unknown. Routine ABO and D serologic typings are performed in our laboratory by automated microplate testing. Until 2011, routine confirmation of D- status of first-time donors was performed by the manual tube indirect antiglobulin test (IAT); this was replaced by automated solid-phase testing including weak D testing by IAT. Selected donors are investigated by other methods. We describe four weak D type 67 (RHD*01W.67) donors whose samples tested as D- by automated microplate and manual methods but were later determined to be D+ by automated solid-phase and RHD gene analysis. Solid-phase serologic and molecular typing results of all four donors were identical. It was identified that the donors are of English-Irish descent; two are brothers and the others are cousins. Transfusion of blood from one of these donors likely resulted in alloimmunization to D in one of three recipients tested since no other documented exposures were identified. Lookback studies determined that two other D- recipients were not alloimmunized.

Blood centers often receive information from individuals after blood donation that should have resulted in their deferral and may attempt to retrieve distributed blood components that did not meet all quality standards and regulations. Typically, the information is discovered or reported only after the components from the donation have been transfused. Blood centers may notify the transfusion service and provide a statement of the potential risk, if any, associated with the blood components, but the transfusion service must decide if further investigation, notification of the transfusing physician, or counseling of the patient is warranted. Currently, postdonation information (PDI) affects an estimated 1 in 600 donations in the United States. Despite the regularity with which PDI occurs, there has been little analysis of the main sources of PDI, associated transfusion risk, or the actual benefit of various actions taken as a result of PDI. However, blood centers attempt to retrieve thousands of components each year for PDI: actions that can cause confusion, concern, and complaints from hospitals and transfusion services. Postdonation information is largely a reflection of the inherent limitations of the current donor screening process, which is error-prone and uses broad, precautionary questions to guard against theoretical or extremely remote risks. This article reviews the most commonly reported PDI and available information on the possible risk associated with the transfused components from the involved donations, to formulate a framework for blood center retrieval actions and hospital notification that is consistent with current regulations and commensurate with the likelihood of adverse outcomes associated with the most commonly reported PDI., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Canada now allows donations from men who had sex with men (MSM) if their last sexual contact with a man was more than 5 years ago. We modelled the impact of this policy on supply and safety. Approximately 4500 new donors will be added and assuming compliance to the new policy remains unchanged, the worst-case scenario predicts the introduction of one HIV-contaminated unit in the inventory every 1072 years. This change will entail negligible additional HIV risk to recipients. A five-year deferral will also protect recipients against the theoretical concern that MSM may represent a group at higher risk of sexually transmitted, emerging blood borne pathogens.

Background: Travel to malaria risk areas such as Mexico is a common source of donor deferral in Canada. On February 21st, 2011 the deferrable regions in Mexico were revised to permit donation if donors travelled to the state of Quintana Roo, Mexico, a popular ocean-side resort area., Materials and Methods: Canadian travel data and malaria deferral rates since 2007 were plotted to examine trends. Deferral records in one centre were accessed from January to April, 2011 to tabulate travel destinations of deferred donors immediately before and after the change., Results: Travel to Mexico and the Caribbean accounts for 63% of general population travel, and travel to Mexico has been increasing (P <0.05). Deferral for short-term malaria risk travel has a strong seasonal trend with peaks in the winter and troughs in the summer. Approximately 36,000 fewer donations were lost following the change, a reduction of 37% from the previous year. Deferrals in one centre increased for Caribbean/Central America after the change (P <0.05) consistent with the seasonal trend, but decreased for Mexico (P <0.05)., Discussion: Deferrals for malaria risk travel are substantial. Careful revision and refinement of risk areas of travel can significantly reduce the burden of deferral.

Background: Adverse donor reactions can result in injury and decrease the likelihood of donor return. Reaction reports captured in the blood center's database provide an incomplete picture of reaction rates and risk factors., Study Design and Methods: We performed an anonymous survey, mailed to 40,000 donors in 2008, including questions about symptoms, height, weight, sex, and donation status. Reaction rates were compared to those recorded in our database. Possible risk factors were assessed for various reactions., Results: The response rate was 45.5%. A total of 32% of first-time and 14% of repeat donors reported having any adverse symptom, most frequently bruising (84.9 per 1000 donors) or feeling faint or weak (66.2 per 1000). Faint reactions were two to eight times higher than reported in our database, although direct comparison was difficult. Younger age, female sex, and first-time donation status were risk factors for systemic and arm symptoms. In females, low estimated blood volume (EBV) was a risk factor for systemic symptoms. Only 51% of donors who consulted an outside physician also called Canadian Blood Services. A total of 10% of first-time donors with reactions found adverse effects information inadequate., Conclusion: This study allowed us to collect more information about adverse reactions, including minor symptoms and delayed reactions. Based on our findings of the risk factors and frequency of adverse reactions, we are implementing more stringent EBV criteria for younger donors and providing more detailed information to donors about possible adverse effects and their management., (© 2012 American Association of Blood Banks.)

Background: Various testing strategies may reduce the risk of Chagas disease transmission in nonendemic, low-prevalence countries. Results of the first year of selective testing of at-risk donors at Canadian Blood Services are reported., Study Design and Methods: Since February 2009, platelets were not produced from at-risk donors. Since May 2010, at-risk donors were tested for Trypanosoma cruzi antibodies. Donors testing positive were interviewed about risk factors, and lookback studies were initiated., Results: There were 7255 at-risk donors of 421,979 donors screened (1.72%). Risk factors were born in Latin America (50.6%), mother or maternal grandmother born in Latin America (28%), and 6 months or more travel history or residence in Latin America (19%). Sixteen (16) at-risk donors had T. cruzi repeat-reactive test results of whom 13 confirmed positive. Eleven of 13 were born in Latin America (nine in Paraguay and two in Argentina), and the other two were born in Canada but had short-term travel history and mothers who had been born in Latin America. Ten of the donors spoke German as their first language (all of those born in Paraguay and one born in Canada). There were 148 previous donations (176 components transfused) evaluated by lookback, of which 28% of recipients could be tested. None were positive., Conclusion: Selective testing has mitigated a small risk to the blood supply with very few false-positive results. Most positive donors were born in a risk country, with a concentration of German-speaking immigrants from Paraguay. Residency or travel alone were not clear risk factors., (© 2012 American Association of Blood Banks.)

Because of the variability of D expression, one method may be inadequate to correctly classify donors with variant RHD alleles. We evaluated the use of a solid -phase automated platform (ImmucorGamma Galileo) to confirm D- test results obtained on first-time donors on the Beckman Coulter PK7300 automated microplate test system. Samples with discordant results were analyzed by serologic tube methods, RHD genotyping using the BLOODchip platform (Progenika) and, if necessary, sequencing. We estimated the number of cases of alloimmunization in women younger than 50 years likelyto be prevented by the addition of Galileo testing. From May 2011 to May 2012, 910,220 donor samples were tested; 15,441 were first-time donors with concordant D- results. Five donors tested D- on the PK7300 and weak D+ on the Galileo; one was found to be a false positive on further testing. On manual testing, the other four donors had positive indirect antiglobulin test results with one to three of the antisera used and were C+. On BLOODchip testing, two donors were classified as D+, and two were assigned a "no call". D variants included weak D type 67, weak D type 9, and two novel variants. Approximately 10 percent of D- units are transfused to women younger that 50 years. Assuming an alloimmunization rate of 30 percent, use of the Galileo would prevent approximately one alloimmunization every 5 to 6 years in this patient group. We conclude that the yield of preventing alloimmunization in this population by adding a second automated seologic testing platform is very low.

Objectives: Using population prevalence data for deferrable diseases/conditions we estimated the Canadian population eligible to donate according to three upper-age limit scenarios., Background: The donor selection criteria limit the number of potential blood donors but relaxing the upper age criteria could mitigate this., Methods and Materials: Forty deferral criteria were identified and their corresponding prevalence data obtained to estimate the number of people excluded by the criteria. The eligible blood donor population was estimated from national census data taking the age limits, deferral criteria and deferral time-period into account. As more than one disease/condition may co-exist, the estimate was adjusted to avoid over-representation., Results: Of about 33 million Canadians aged 17 (18 in Québec) to 65, 15·1 million (45·8%) are eligible to donate blood. This number increases to 15·7 million when including people up to 71 years and to 17·1 million in the absence of an upper age limit., Conclusion: As about 1·2 million units are collected from 600,000 donors annually, there are more than enough eligible people to meet the need. However, recruitment of donors is challenging and the absence of an upper age limit allows an additional 2 million people to donate. Other countries may wish to consider modification of the upper age criterion to address the effect of an aging population on the blood supply., (© 2012 The Authors. Transfusion Medicine © 2012 British Blood Transfusion Society.)

Background: Few donor criteria are as contentious as the deferral of men who have had sex with men (MSM). We performed an anonymous donor survey to determine attitudes toward current screening and the feasibility and acceptability of adoption of alternate donor criteria for MSM., Study Design and Methods: Donors who had successfully donated to Canadian Blood Services were randomly mailed an anonymous questionnaire several weeks after donation; there were 40,000 donors sampled, evenly split between first-time and repeat donors., Results: The response rate was 45.5%. The vast majority of donors found the current screening questions and clinic environment acceptable. Attention to clinic educational materials was poor. A total of 53% felt that the MSM criteria should be changed; many were supportive of criteria based on specific behaviors rather than a period of abstinence. Gender-neutral questions such as number of sexual partners would result in deferral of large numbers of donors., Conclusion: Many donors would support a change in MSM deferral policy. Implementation of strategies based on donor attention to additional material would be challenging. Universal use of simple gender-neutral questions would result in very high donor loss and are therefore not an acceptable option. The acceptability and feasibility of various screening approaches should be explored further with both donors and advocacy groups., (© 2011 American Association of Blood Banks.)

Background: Immunoglobulin A (IgA)-deficient patients with antibodies to IgA require transfusions with IgA-deficient blood components to either avoid or reduce the frequency of serious adverse reactions. To supply compatible blood components for these individuals, the Canadian Blood Services (CBS) National Testing Laboratory must initially screen and subsequently identify, after confirmatory testing at the American Red Cross (ARC), donors severely deficient in IgA (<0.05 mg/dL)., Study Design and Methods: The Ouchterlony double immunodiffusion assay was used as an initial screen at CBS to identify IgA-deficient donors (test sensitivity 2-4 mg/dL). Sample aliquots from these donors were then sent to the ARC for confirmatory testing using an enzyme-linked immunosorbent assay method for severe IgA deficiency (<0.05 mg/dL) and a passive hemagglutination assay to detect anti-IgA., Results: From November 2007 to December 2008, of 54,594 samples screened initially at CBS there were 137 samples (0.251%) identified as possibly IgA deficient. Of these 137, there were 100 reports returned from ARC confirming severe IgA deficiency in 65 donors (25 female, 40 male) without detectable anti-IgA and in 35 donors (18 female, 17 male) with anti-IgA. The remaining 37 donors had IgA levels of more than 0.05 mg/dL., Conclusion: Results from the ARC confirmed a frequency of 1 in 546 in the CBS' blood donor population for severe IgA deficiency (<0.05 mg/dL), 1 in 840 for those without anti-IgA, and 1 in 1560 for those with antibody. Donors repeatedly confirmed as severely IgA deficient without anti-IgA were considered eligible for the CBS IgA-deficient donor registry program.